510(k) K022398
- Device
- REUSABLE BRONCHIAL BIOPSY FORCEPS
- Applicant
- BALLARD MEDICAL PRODUCTS
- 510(k) number
- K022398
- Product code
- BWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-11
- Date received
- 2002-07-23
- Regulation
- 874.4680
- Classification name
- Forceps, Biopsy, Bronchoscope (non-rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CINDY ELLIS
- Address
- 12050 Lone Peak Pkwy. Draper UT US 84020 84020
FDA Registration Numbers#
- 3008252486
- 3007738736
- 1061927
- 3007695959
- 3004962788
- 3005099803
- 1056129
Source Documents#
Other 510(k) Records For Product Code BWH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | 2025-09-26 |
| K121186 | RADIAL JAW 4 PULMONARY BIOPSY FORCEPS | Boston Scientific Corp | 2012-05-16 |
| K102336 | RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE | Boston Scientific Corporation | 2011-01-24 |
| K930419 | WILTEK BIOPSY FORCEPS | Wiltek Medical, Inc. | 1993-06-01 |
| K843282 | UNIVERSAL BY RUSH-HAMPTON ARTHROSCOPIC | Rush Hampton Industries | 1984-10-22 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases